Sr. Customer Quality Engineer

We anticipate the application window for this opening will close on – 28 Oct 2025

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

In this exciting role as a Sr. Customer Quality Engineer, you will be a close partner of the Acute Care & Monitoring OEM customers. Our OEM customers or Strategic Alliance Partners, who are among the leading Medical Device companies in the world, integrate our products into their devices, and as such they require the highest standards of quality, reliability and safety.

In this role, you will have the responsibility for managing a variety of quality activities related to the Acute Care & Monitoring Strategic Alliance customers, including working closely with the R&D group on integration acceptance testing and root cause investigations, working closely with our manufacturing sites to ensure quality controls are in place, communicating with customers concerning quality issues and driving for resolution and continuous improvement, responding to ongoing customers’ requests and inquiries and work closely with the Marketing team to address any customer quality needs.
Responsibilities may include the following and other duties may be assigned.

• Review test reports supporting Strategic Alliance customers integration acceptance testing.
• Review non-product tool validation protocols and reports:
• Assist with testing strategies and report formats
• Complete risk analysis
• Understand Hardware and Software elements
• Handle Strategic Alliance Partner complaints and requests for Corrective Actions (SCARs):
• Drive root cause investigations and internal actions such as Corrective and Preventive Actions (CAPA), Product and Process Changes (CDPs).
• Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
• Review complaint trends and provide input to Medtronic CQXM (Customer Quality Experience Management) team from a Strategic Alliance customer standpoint
• Track of SCARs and reporting of SCAR metrics
• Specify inspection and testing mechanisms for material that is non-conforming
• Perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications
• Drive for continuous improvement and updates to processes, templates and documents.
• Respond to Quality related questions from Customers via the web Portal or E-mail sources.
• Provide information on Materials of Concern.
• Provide Certificate of Conformance
• Provide technical data to support Strategic Alliance Partner regulatory submission
• Support Marketing with the PCN (Product Change Notification) process and customer communication plan.
• Assist Medtronic Regulatory Affairs with Quality related information and declarations.
• Assist Medtronic Legal with Quality related input on Customer Agreements (Quality agreements, notification agreements, etc.).
• Oversee of ISO compliance and testing related to OEM products:
• Raising awareness of ISO standard updates, driving for updating test reports.
• Providing input to R&D testing as it relates to OEM components.

• Bachelor’s degree required
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience

• Project Management experience or training
• Experience working with customers
• Knowledge with Six Sigma or DRM
• Strong analytical and problem-solving skills
• Excellent communication skills
• Ability to work effectively independently, within teams, and across functions.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the…